PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy
PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential measurement inaccuracy without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling the AutoDELFIA hCG Kit, an in vitro diagnostic used for the quantitative determination of human gonadotropin (hCG). The recall involves 79 kits, with none distributed in the United States and all located in regions outside the US (ROW). The kits were distributed worldwide, including in Austria, Bolivia, the UK, Switzerland, and Thailand.
The recall was initiated because hCG analyte concentrations may be decreased by 15-20% at the lower measuring range of hCG concentrations. This potential inaccuracy could affect the reliability of test results in that specific range.
The affected products are identified by Kit Lot Numbers 664670 and 666553, and Pack Lot Numbers 1066467001, 1066467002, and 1066655301. Users of these kits should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
- Hazard
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Lot Numbers: 664670
- 666553 Pack Lot Numbers: 1066467001
- 1066467002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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